Validation of Digital Pathology In a Healthcare Environment
Elizabeth A. Chlipala, Jesus Elin, Richard E. Long, Jared N. Schwartz, Anil Vasdev Parwani · 2011
Digital pathology is a dynamic, image-based environment that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide. The Digital Pathology System (DPS) includes a whole slide scanner (WSS), image acquisition software, image viewing and database software, image analysis software, and the necessary IT infrastructure to support the DPS. Validation is an ongoing process to establish documented evidence that provides a high degree of assurance, that a process or system will consistently perform according to predetermined specifications and quality attributes. To date, efforts to validate digital pathology systems in a clinical healthcare environment have been very limited. Therefore the strengths and weaknesses of validation are essentially unknown. Documentation from governing organizations such as the Food and Drug Administration (FDA), Centers for Medicare and Medicaid (CMS), and the College of American Pathologists (CAP) around validation practices is scarce. Attempts at validation of digital pathology systems are likely limited due to a lack of understanding on how to efficiently conduct a validation and how to navigate regulations that could have an impact on laboratory accreditation and healthcare compliance. Validation of a digital pathology system (DPS) is necessary for clinical use to ensure laboratory compliance for CLIA, State regulations, The Joint Commission, and CAP accreditations, to protect patient safety and confidentiality, to assure digital pathology data is accurate, and to maximize the value of a DPS. This white paper will not provide a step by step approach to validation. It will serve as a high level overview of what should be considered, while aligning with other resources available to the pathology community including CAP Checklists and the recently published CAP draft guidelines for “Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology.” (1) This white paper will use a key code to help readers naviagate the information based on their role in validation.